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QA consultant

Introduction


Interested to start your career as a consultant at XPE Pharma & Science? We are looking for a QA Consultant.


Company/Department


Why work as a consultant for XPE Pharma & Science?

  • XPE is a part of Adecco, one of the Top 5 companies within the 'Great Place to Work' ranking
  • Dynamic colleagues with passion and drive
  • The opportunity to develop yourself, your competences and skills within our organization
  • An interesting salary with extra-legal benefits. We offer meal vouchers, group- and hospitality insurance.

Function information


As a QA Consultant you will support the development of GMP training packages and, if necessary, delivery of training. Under the direction of the reporting manager, you will continuously improve QA and Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.

Your responsibilities are:

Provide QA support for:

  • Investigation and closure for the Deviation and the Out Of Specifications
  • Change Control initiation and implementation
  • CAPA initiation and implementation
  • Documentation and records review:
  • Procedure, Master Batch Record, Specifications…
  • Batch records and associated documents after production
  • Control Cleaning Records
  • Maintain the calibration program and the monitoring for the facilities up to date

Documentation System Management:

  • Traceability (controlled copy, follow-up approvals,…)
  • Official documents distribution
  • Maintain the training files and the archives area up to date

Other activities:

  • Work with relevant departments to ensure timely closure of quality actions
  • Actively contribute to continuous improvement initiatives
  • Perform inspections/internal audits
  • Collaborate with the different departments to resolve compliance matters


You must be able to:

  • Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
  • Use a risk based approach for problem solving and prioritization of tasks
  • Blow a quality and compliance mindset through the validation activities
  • Develop and continuous improve expertise linked to the primary validation activities – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
  • Be a strong advocate for validation approaches and activities during internal and external audits

Requirements


As a QA Consultant you have a University degree (Biotechnology, Sciences, Chemistry or Pharmacy) and at least 2 years professional experience in pharmaceutical environment.

You have good interpersonal relationship skills, you are a team player in order to success in each project. You have good oral and written communication skills in French or Dutch & English. You can easily solve problems and you are result oriented.


Offer


You need more information? Call me!

Andrea Baetens

+32 10 80 71 15


Information


Andrea Baetens

+32 10 80 71 15


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